Multiple Sclerosis (MS) is an autoimmune disease of the central nervous system (CSN) (Thompson et al., 2018). Most of the patients present initially a relapsing remitting (RR) phase characterized by reversible neurological deficits (University of California, San Francisco MS-EPIC Team 2016). Afterwards, patients invariably experience a progression phase characterized by gradual worsening of disability (University of California, San Francisco MS-EPIC Team 2016). As novel agents are becoming available for the treatment of secondary progressive MS (SPMS), identifying the progression as early as possible is crucial to maximize their efficacy (Ontaneda et al., 2015; Kappos et al., 2018; Giovannoni et al., 2010).

Despite the efforts of the researchers, the diagnosis of the progression phase is still retrospective and based on the objectivation of clinical disability accumulation. In the last decades researchers have attempted to identify predictors of disease progression to grasp as early as possible the transition of disease in the secondary progressive phase (Misicka et al., 2020; Barzegar et al., 2021; Alroughani et al., 2015). Some demographic, clinical and radiological features revealed to have a prediction value in term of progression (Barzegar et al., 2021; Alroughani et al., 2015). However, in some cases, study findings concerning some of the most relevant predictors are controversial.

In 2009, FDA defined Patient Reported Outcome Measures (PROMs) as “any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else” (U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research 2009). PROMs allow patients to self-report their symptoms, functioning, and quality of life in multiple domains (Lanzillo et al., 2020; Abbadessa et al., 2021). The concept of PROMs has gained attention in the medical field due to its potential to provide a more comprehensive and holistic view of disability in MS (Abbadessa et al., 2021).

In this study, we aim to: (i) describe the correlations among the selected PROMs in RRMS patients; (ii) assess whether the score obtained at the PROMs may predict disease progression within three years of follow-up, and (iii) investigate which of their single components is most closely associated with the outcome (progression within three years of follow-up).

Identifying which components of PROMs most accurately predict disease progression in the following three years would provide neurologists with an additional tool to predict the patient's disease progression and thus, supporting early identification of the transitional phase, allowing early treatment switch to more appropriate drugs.